Recall archive / FDA device enforcement
Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or... — FDA record Z-0410-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 17, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK967
- Reason
- Kit packaging may have small holes compromising product sterility
- Classification
- Class II
- Recalling firm
- Beaver Visitec International, Inc.
- Quantity
- 1170 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0410-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Numbers: 3347922, 3350452, 3354937, 3358047, 3364371 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
CA, CO, LA, MA, MD, ND, PA, TN, UT
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 29, 2021
- Recall initiation date
- Nov 17, 2021
- Center classification date
- Dec 21, 2021
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.